NDC 50242-041

Cathflo Activase

Alteplase

Cathflo Activase is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Alteplase.

Product ID50242-041_02610895-08f1-4af5-a022-265a2c36c795
NDC50242-041
Product TypeHuman Prescription Drug
Proprietary NameCathflo Activase
Generic NameAlteplase
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2001-09-04
Marketing CategoryBLA / BLA
Application NumberBLA103172
Labeler NameGenentech, Inc.
Substance NameALTEPLASE
Active Ingredient Strength2 mg/2mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50242-041-10

10 VIAL in 1 CARTON (50242-041-10) > 2 mL in 1 VIAL
Marketing Start Date2019-10-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-041-64 [50242004164]

Cathflo Activase INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103172
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-09-04

NDC 50242-041-10 [50242004110]

Cathflo Activase INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103172
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-14

Drug Details

Active Ingredients

IngredientStrength
ALTEPLASE2.2 mg/2mL

OpenFDA Data

SPL SET ID:91ecdef2-95ff-42dd-a31c-c8a09cab3ad9
Manufacturer
UNII

Medicade Reported Pricing

50242004164 CATHFLO ACTIVASE 2 MG VIAL

Pricing Unit: EA | Drug Type:

50242004163 CATHFLO ACTIVASE 2 MG VIAL

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Cathflo Activase" or generic name "Alteplase"

NDCBrand NameGeneric Name
50242-041Cathflo ActivaseAlteplase
50242-044ActivaseAlteplase
50242-085ActivaseAlteplase

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